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临床试验/NCT04926337
NCT04926337已完成不适用

Preoxygenation With High-flow Nasal Oxygen in Comparison to Standard Face Mask in Adult Trauma Patients During Rapid Sequence Induction Anesthesia- a Prospective, Non-randomized, Before-and-after Study

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
104
试验地点
1
主要终点
Number of patients with a peripheral oxygen saturation (SpO2) below 93%

研究概览

简要总结

Previous studies investigating apnoea oxygenation has shown that delivering oxygen via a high flow can maintain adequate oxygen saturation levels in a patient for over 30 minutes.

It has recently been demonstrated, in several studies, that High Flow Nasal Oxygen (HFNO) used during preoxygenation in patients undergoing emergency surgery is at least equally effective as preoxygenation with standard tight fitting mask. Data from these recent studies investigating arterial oxygen saturation levels during rapid sequence induction anaesthesia have not been able to detect any difference between the two methods. The mean apnea time among the patients in the previous studies have been relatively short.

Patients suffering traumatic injuries could be more prone to desaturate during prolonged apnea due to being hemodynamic unstable or suffering injuries to the respiratory tract.

Based on the above, the aim is now to conduct a trial where trauma patients are preoxygenated with high flow nasal oxygen before anaesthetised with rapid sequence induction (RSI) technique. The trial is set to be a before-and-after study. During approximately 6 to 9 months data will be registered from trauma patients undergoing emergency anaesthesia where preoxygenation is performed according to standard rutin, with traditional facemask. During the coming six to nine months trauma patients undergoing emergency anaesthesia will be preoxygenated with high flow nasal oxygen. Data will be registered and compared to the data collected from the patients preoxygenated with facemark.

The general purpose of this project is to compare the preoxygenation technique based on HFNO with traditional preoxygenation with a tight fitting mask, with the main focus being oxygen saturation levels, during rapid sequence induction (RSI) intubation in trauma patients in need of immediate anaesthesia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1 Adult, ≥18 years old
  • 2 Level 1 trauma with patients in need of emergency anaesthesia before leaving the trauma unit (trauma room or nearby operating theatre).

排除标准

  • 1 Patients with or with risk of skull or facial injuries where application of nasal cannula is decided to be avoided by the trauma team.

结局指标

主要结局

Number of patients with a peripheral oxygen saturation (SpO2) below 93%

时间窗: From start of anaesthesia until 1 minute after tracheal intubation.

Compare the number of patients with a peripheral oxygen saturation (SpO2) below 93% from induction of anesthesia (when induction drug is administered) until one minute after intubation between the group preoxygenated using HFNO and the group preoxygenated with traditional tight-fitting mask.

次要结局

  • Time span from start of preoxygenation until intubation.(Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.)
  • Lowest median SpO2.(From start of anaesthesia until 1 minute after tracheal intubation.)
  • Frequency of complications(Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.)
  • End tidal gas levels(At the first breath after tracheal intubation.)
  • Difficulties with induction of anaesthesia(Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.)
  • Time span from entering trauma room until intubation.(Could vary depending on patient and trauma, from a couple of minutes up to an hour.)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Malin Jonsson Fagerlund

Senior consultant, Associate Professor

Karolinska University Hospital

研究点 (1)

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